Program Director/Principal Investigator (Last, First, Middle): Slowey, Paul D. Abstract This phase I NIH SBIR proposal seeks support for an interdisciplinary partnership between Oasis Diagnostics and Iowa State University who collaboratively seek to develop a novel tool that can measure and quantify levels of the sex hormone testosterone in saliva within minutes of collection: VerOFy testosterone. The FDA has urged caution regarding clinical use of T replacement therapy, calling for more research and greater differentiation of clinical vs experimental application, noting that ?low T? is often treated without being measured once or more frequently. We share this cautionary tone and designed VerOFy testosterone to better understand how T works endogenously in the body and changes in response to situational context at the moment, at the point of care, and non-invasively using saliva specimens. Currently, it is impossible to uncover T changes until days to weeks later, which poses a critical barrier to research or monitoring applications. The present proposal targets T in order to make a strong impact on risky decision making research. Risky decisions, especially in young populations, impact on mental and physical health outcomes, such as drug initiation and abuse, risky sex, accidents and early mortality. The applications for POC T testing go well beyond the implications for decision making in the research community, and the true size of the market is much larger with applications in the fields of neurobiology, neuroendocrinology, psychobiology, gender development, professional sports teams, sports medicine, fitness, stress and wellness. Rapid, quantitative salivary T measurement may be convenient for novel applications on the physiology of competitive sports and performance enhancement. The commercial potential is estimated to be high based on a growing billion-dollar hormone testing industry and a burgeoning wellness market. The product to be developed is a rapid point-of-care, non-invasive Testosterone (T) assay. This technology, based upon the VerOFy proprietary technology, is comprised of (a) the SuperSal? Extra Saliva Collection device, (b) the analyte-specific LFT cartridge and (c) the LIAM? (Litebox Image Analysis Module) reading device with portability to mobile technologies. This builds from our prior success in developing VerOFy cortisol which shows that this team can feasibly deliver SBIR-relevant results. No other commercial entity has created an LFIA point-of-care platform that provides immediate results for T from saliva. Quantitative T assessment in saliva at the POC is innovative in itself; we further propose innovations. We will expand detection of single analytes into a unique saliva multiplex assay format which simultaneously and delivers T and C results within minutes. This opens up the opportunity for further salivary point-of-care biomarker panels with near instant results. We will enhance product mobility for individual multipoint monitoring through Bluetooth compatibility and customizable algorithms available to the user through a Smart Phone App. Since T can change dramatically within a short period of time, for research and monitoring purposes, the ability to receive results within minutes is critically important to visualizing T in a physiologically responsive manner. OMB No. 0925-0001/0002 (Rev. 08/12 Approved Through 8/31/2015) Page Continuation Format Page